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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EVA SELECT DIRECT - D83399924131050

EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution

  • D83399924131050 ()
9992413105

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131000

EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution

  • D83399924131000 ()
9992413100

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924122000

EVA SELECT SIZE 2 SYSTEM
ImageWorks
9992412200
In Commercial Distribution

  • D83399924122000 ()
9992412200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924121000

EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution

  • D83399924121000 ()
9992412100

  • Dental digital imaging sensor, intraoral
  • General-purpose dental x-ray system application software

Welch Allyn, Inc. - 00732094264999

E-Scribe ECG Data Management Workstation - Rx system, floating; English system language; 220V power; Tower workstation computer hardware (no keyboard, mouse, or display); 19 in. display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094264999 ()
ESWKST-FAB-AAXXX

  • Patient health record information system application software

PATRAN Slide Sheets - 00850050415169

PATRAN® dispensers, holds one box of any style PATRAN® slide sheets, 11”W x 9.5”L x 4”D, mounting hardware included. Made of PET.
Jamar Health Products, Inc.
9622 Dispenser
In Commercial Distribution

  • 00850050415176 ()
  • 00850050415169 ()


  • Patient transfer sliding mat

Welch Allyn, Inc. - 00732094265064

E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display); 24 in. widescreen display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265064 ()
ESWKST-DAA-ABXXX

  • Patient health record information system application software

Alinity c ACE Assay File - 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD

ARCHITECT c ACE Assay File - 08058056685438

The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD

MediChoice - 10885632142543

Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 18-20 Inch Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2CA
In Commercial Distribution

  • 20885632142540 ()
  • 10885632142543 ()


  • Wheelchair wheel

VISIUSmatrix - 00857534006684

Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution

  • 00857534006684 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006677

Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution

  • 00857534006677 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006660

Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution

  • 00857534006660 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006653

Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution

  • 00857534006653 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006646

Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000
IMRIS Imaging, Inc.
Application Platform 4.0 KIT
In Commercial Distribution

  • 00857534006646 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006639

Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution

  • 00857534006639 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006622

Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution

  • 00857534006622 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006493

Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006363

Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution

  • 00857534006363 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

Clear Guide Optical Head - B201CGOHM0

The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system

Clear Guide Optical Head - B201CGOH0

The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution

  • B201CGOH1 ()
  • B201CGOH0 ()
CG-OH

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system

Buzz 2.0 - 04056481140977

No Description
Brainlab AG
15800
Not in Commercial Distribution

  • 04056481140977 ()


  • Medical image management system
  • Radiology picture archiving and communication system workstation

X-Guide - 00817421021435

BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021411

BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021398

BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
P010306
In Commercial Distribution

  • 00817421021404 ()
  • 00817421021398 ()
  • 00817421022715 ()
P010306

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021374

BONE SCREW, EDX - 2.7Ø x 16mm
XNAV TECHNOLOGIES LLC
P010305
In Commercial Distribution

  • 00817421021381 ()
  • 00817421021374 ()
  • 00817421022708 ()
P010305

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021350

BONE SCREW, EDX - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P010304
In Commercial Distribution

  • 00817421021367 ()
  • 00817421021350 ()
  • 00817421022692 ()
P010304

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021336

BONE SCREW, EDX - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P010303
In Commercial Distribution

  • 00817421021343 ()
  • 00817421021336 ()
  • 00817421022685 ()
P010303

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

Vios Monitoring System Central Station Monitor - B595CSM20500

The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CSM2050 Software
In Commercial Distribution

  • B595CSM20500 ()
CSM2050

  • Centralized patient monitor
  • Cardiac arrhythmia monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
  • Pulse oximeter
  • Clinical management support software

MediChoice - 10885632142550

Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 22-24 Inch Heavy Duty Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2HDCA
In Commercial Distribution

  • 20885632142557 ()
  • 10885632142550 ()


  • Wheelchair wheel

AURA 10 PET-CT - 05430002734026

Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD

Matrx Elite HD Back - 07540147000158

Elite Heavy-Duty Back Support. (3" contour depth; 500lb weight capacity). HD mounting hardware included. Matrx Elite backs are designed to provide precise orientation within the wheelchair for optimal postural support.
Motion Concepts Inc
PBE-HD
In Commercial Distribution

  • 07540147000158 ()
PBEwwhh-HD

  • Wheelchair back rest

4K3D Video Microscope HawkSight - 04589698450602

No Description
MITAKA KOHKI CO., LTD.
KV3
In Commercial Distribution

  • 04589698450602 ()


  • General-purpose surgical microscope
  • Neurosurgical microscope
  • Video camera surgical microscope system
  • Microscope video camera
  • ENT surgical microscope
  • Surgical microscope fluorescent angiography system
  • Surgical microscope video camera, non-sterilizable
  • Medical video image recorder

IntelliSpace Clinical Applications - 00884838074804

Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
8.x
In Commercial Distribution

  • 00884838074804 ()
837509

  • Radiology picture archiving and communication system workstation

IntelliSpace Clinical Applications - 00884838125940

IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as, but not limited to, CT and MRI, or from image archives. IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838125940 ()
837509

  • Radiology picture archiving and communication system workstation

IntelliSpace Clinical Applications - 00884838091849

Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Healthcare Informatics, Inc.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838091849 ()
837509

  • Radiology picture archiving and communication system workstation

Software web Showmotion - 08051122041091

Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.
NCS LAB SRL
SHWM01SW1
In Commercial Distribution

  • 08051122041091 ()


  • Biomechanical function analysis/rehabilitation software

NOVA View® AUTOLoader - 08426950643708

The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.
INOVA DIAGNOSTICS, INC.
ALDR1000
In Commercial Distribution

  • 08426950643708 ()


  • Cell morphology analyser IVD, automated/semi-automated

Matrx Elite Deep HD Back - 07540147000110

Matrx Elite Deep Heavy-Duty Back Support. (6" contour depth; 500lb weight capacity). HD mounting hardware included. Matrx Elite backs are designed to provide precise orientation within the wheelchair for optimal postural support.
Motion Concepts Inc
EDB-HD
In Commercial Distribution

  • 07540147000110 ()
EDBwwhh-HD

  • Wheelchair back rest

RamSoft - B359PSPACS6PRU11B0

RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSPACS6PRU11B0 ()
PSPACS6PRU11B

  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software

EchoGo - 05060634690065

No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690058

No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690041

No Description
ULTROMICS LIMITED
Heart Failure 1.0
In Commercial Distribution

  • 05060634690041 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690027

No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution

  • 05060634690027 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

EchoGo - 05060634690003

No Description
ULTROMICS LIMITED
Core
In Commercial Distribution

  • 05060634690003 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software

MiSeqDx Instrument - 00816270020002

The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software.
ILLUMINA, INC.
15036706
In Commercial Distribution

  • 00816270020002 ()
DX-410-1001

  • Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

One-Piece Flat Calf Panel Assy - 07540147002473

One-Piece Flat Calf Panel Mount Assy designed for use with Motion Concepts CM Legrests (includes mounting hardware). One-Piece Calf Pad sold separately. Available in a variety of widths and heights to accommodate different user needs.
Motion Concepts Inc
D-0101-0157-OSCPL
In Commercial Distribution

  • 07540147002473 ()
OSCPL

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad

Extended Mounting Pins - 07540147000622

Extended Mounting Pins (4pcs). Hardware for Matrx Elite, E2 Backs (18H/20H) and PB Backs. Extended pins allow mounting onto back canes up to 2" wider than nominal back width (up to 20" back widths).
Motion Concepts Inc
EMP
In Commercial Distribution

  • 07540147000622 ()
EMP

  • Wheelchair back rest positioner pin

Fixed Joystick Mount - 07540147001971

Fixed Joystick Mount Assembly. Components/hardware used to fix-mount a wheelchair joystick to the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-FJ
In Commercial Distribution

  • 07540147001971 ()
FJ

  • Wheelchair bracket/mount

Flat Hand Pad - 07540147002718

Flat Hand Pad. (Molded, skinned polyurethane hand pad designed for use in combination with the Ergonomic Arm Trough (sold separately)). The Flat Hand Pad is compatible with Left or Right Arm Troughs. Mounting hardware is included.
Motion Concepts Inc
D-0153-FHP
In Commercial Distribution

  • 07540147002718 ()
FHP

  • Wheelchair armrest
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